coordination centre for clinical trials (kks) · pdf filesupport provided by kks •...
TRANSCRIPT
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Support provided by KKS
• Academic, non commercial trials
• Support of all aspects of clinical research
– Sustainable, quality-assured study projects
• Optional services
– For members of the University Hospital and for others
• Independence from University departments
– No own academic ambitions
• Cost recovery
31.12.2011 (FTE / Function)
Head (1)
Administration (1,4)
HR (0,4)
Scientific PM (4,9)
IT (2,9)
Pharmaco- vigilance (2,6)
Biometrics (1)
Training (1,5)
QA/ Audits (1,5)
Clinical Monitoring
(11)
Site Management
(1,4)
Data- Management
(4,5)
IEC / CA Procedures
(0,7)
Cooperations: FIM HD - First in Men Heidelberg; joint unit with different
clinical partners
IMBI Institute for Medical Statistics and Informatics
NCT National Centre for Cancer
SDGC Study Centre of German Society for Surgery; joint unit with Dept. Of Surgery
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Output Figures
* only projects with contracted KKS-participation are considered
overall 187 studies since 2000
Active Studies Anzahl Funktionen in aktiven Projekten / Jahr
1015 27
37
45
59 5864
75
89 8790
1,5 1,6 1,7 2,0 2,1 2,2 2,32,7 2,8 2,9 2,9 3,1
0
10
20
30
40
50
60
70
80
90
100
2000 2005 2010
0
1
2
3
4
5
6
7
8
9
10
Zusammenfassung
Funktionen Durchschnitt
Projekte [n]Funktionen Ø
Projects [n]
Projects [n] Tasks/ Project {n]
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Output Figures
* only projects with contracted KKS-participation are considered
Legal Framework 2011*
AMG = Arzneimittelgesetz (German Drug Law), MPG = Medizinproduktegesetz (German Medical Device
Law), BtmG = Betäubungsmittelgesetz (Narcotics Law), BfS = Bundesamt für Strahlenschutz (German
Federal Office for Radiation Protection), Frei = Not regulated by specific law
Rechtlicher Rahmen 2000ff
132
27
1 9
5350
10 0 3
29
0
20
40
60
80
100
120
140
AMG MPG BtMG BFS FREI
2000ff
2011
[n]
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Output Figures
Tasks Assumed by KKS
* only projects with contracted KKS-participation are considered
PM = Project Management MO = Clinical Monitoring
SN = Study Nurse Activities BM = Biometry
DM = Data Management QA = Quality Assurance
PV = Pharmacovigilance
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Consultations
Output Figures
Expenditure 2011
• N=161
• ∑ 440 h, Ø 2.7 h,
Several staff members (BM,
PM, IT, QA etc.) involved,
when necessary
• Specific services, such as
providing templates, etc.
Compensation
• Generally free of charge
Contents
• General
– AMG, insurance, etc.
• Project-related
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Personnel Development
n
Personnel
Growth through
• Extension of existing tasks
• New tasks
• More comprehensive projects
Competence through
• Long-term employment
• Structured initial training and
professional development
• Internal and external further
education
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Funding Shares
Finances
0%
20%
40%
60%
80%
100%
2000 2005 2010
BMBF-Funding
Overhead
Faculty
Third Party Funds
Safety Reports SAE Meldungen
13
131
2 7 12
238
74
240
50
100
150
200
250
2008 2009 2010 2011
SAE
Follow Up-Report
SUSAR
[n]
∑ 26
∑ 94
∑ 381
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Clinical Monitoring / CRA
• (on-site) support and monitoring of clinical trials
– Adding to competence of investigators and
coordinating investigators (LKPs)
– Continuous quality control, adapted to each study
and risk assessment
Objective
– Support of trial site
– Protection of trial subjects
– Best data quality and integrity
– Compliance with protocol and regulatory
requirements
KKS Services
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Scientific Study Support / PM
• Unbureaucratic, confidential project consultation
• Study design and trial protocol development
• Project management
– Ethics, regulatory affairs, (drug) safety
• Broad experience, independent of indication
– AMG, MPG, non-AMG/ non-MPG, RöV, StrV, etc.
– Comprehensive templates
• Document review
• Submission procedure to DFG, BMBF, EU etc.
• Consultation regarding research structure and
contracts
KKS Services
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Site Management Organization (SMO)
• On-site support of the clinical trial
– Scheduling of patient visits, conduct, documentation
– Sample logistics
– Preparation/ support of visits of (external) monitors
and auditors
– Updating of central documents (ISF)
Objective
– Well-planned and timely executed clinical trials
– Relief of medical personnel
KKS Services
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Biometry
• Conceptual consultation
– Study design, sample size, etc.
• Biometric parts of the protocol
• Randomization procedures
• Statistical Analysis Plan, analyses
– Sensitivity analyses for model assumptions and
missing values
• Participation in the integrated final report
KKS Services
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Data Management
• Implementation of the clinical trial protocol
– Variable lists
– Case Report Forms (paper based, RDE)
• Data entry masks
– Development, validation and data entry
– Training for RDE systems
• Data Validation Plan (DVP)
– Incl. query tracking
• Central randomization
• Support for the analysis
KKS Services
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Quality Management
• SOP system – Development, refinement and maintenance
– Staff Training (incl. documentation)
– Harmonized with the KKS Network and the TMF (Telematic Platform for Medical Research)
• Improvement of the staff's professional skills – On-the-job training and development plans
– Internal and external training
• Consultancy services for trial centers
• QA review of essential documents
• Internal Audits
KKS Services
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IT Services
• Validated systems for – Primary data entry in electronic format (RDE)
– Data management
– Statistical analyses
• Processes defined in SOPs
• Conceptual tasks regarding „IT-landscape“
Clinical Research in Heidelberg
KKS Services
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Pharmacovigilance
Tasks
• Workflow Definition (Safety Manual)
• Preparation of the study-specific data base
• SAE Management
• Follow-up of SAEs (obtaining of missing information)
• SAE/SUSAR Reporting
• Preparation of Annual Safety Report(s) (ASR)
KKS Services
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Training
• Continual training offers – Impart practical knowledge
– Qualification of attendees
– Improvement of training situation in clinical research
• Curricula of several days or weeks for – Investigators
– Study Nurses
– Clinical Monitors
• Topical lectures and training – E.g. on recent amendment to the German Drug Law, drug
safety, sponsor‘s role
• Lecture Series on Clinical Trials – Continual education as required by ICH GCP
KKS Services
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Compulsory Consultation
• Support the principal/coordinating investigator (LKP) in
1. Designing clinical trials in compliance with German Drug Law,
GCP Ordinance, data protection law, etc.
2. Completely define the responsibilities associated with the clinical
trial
3. Avoiding funding shortfall
• Protection of the faculty‘s interests
Indirect
• Synergetic effects for parallel projects
• Enhancement of the reputation and competitiveness of
clinical research
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Supervision of the Sponsor‘s Activities
Coordinating
Investigator
(LKP according AMG)
IEC
KKS Approval;
EC Application
Administration/
Legal Department
KKS
Contracts Interchange
According to the Medical Faculty Executive Committee Resolution of February, 2nd 2007
2. Internal
Audit
1. Compulsory
Consultation
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Auditing
• Support for external audits and inspections
• Recommendations for corrective actions
• Audits on behalf of Medical Faculty
– Focus: trials regulated by the German Drug Law
with principal/coordinating investigator in
Heidelberg
– Supervision of the sponsor‘s activities
KKS Services
FIM Heidelberg
First in Man Studies ...
• „One stop shopping“ strategy (planing, conducting and reporting)
• Multidisciplinary
– KLIPS (Phase I Study Site on Clinical Pharmacology)
– KKS (Coordination Centre for Clinical Trials)
– IMBI (Medical Biometrics and Statistics)
– NCT, DKFZ (pre- and clinical oncology)
– Further clinical partners
• Contact http://fim-hd.kks-hd.de
Email: [email protected]
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National
•
• SDGC, Chir-Net
• TMF (Telematikplattform) (German meta-organisation for networked medical research)
• Competence Networks
International
• European network
(Inter)national Activities
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Interaction with funding organisations, currently regarding
• Pay scale grouping in grant applications – TV-Ä*, TV-L#
• Applicability of GCP in psychotherapy trials
• Financing plans for clinical trials – Overhead costs, full costs
• Review process and statement for grant notification – E.g. Integrated Research and Treatment Centers (IFB):
43 applications, only 3 accepted, reasons?
Exchange with ministries
• Comments on draft laws – Currently: German Radiation Protection Ordinance, X-Ray Ordinance,
Drug Guidelines (AMR)
*Sector pay scale for University Hospitals # Public Sector Collective Agreement on Länder
Activities